Assyro AI

Orange Book product · Brand (NDA)

EXEM FOAM KIT

AIR POLYMER-TYPE A

Brand (NDA)NDA 212279RX GISKIT

At a glance

Nov 07, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 07, 2019

    6 yr 9 mo ago

  2. Today

  3. Patent 9034300 expires

    Listed drug product patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

  4. Patent 9259494 expires

    Listed drug product patent expiration.

    May 04, 2035

    in 9 yr

  5. Patent 9849199 expires

    Listed drug product patent expiration.

    Feb 11, 2036

    in 9 yr 9 mo

Pharmaceutical detail

Active ingredient

AIR POLYMER-TYPE A

Strength

10ML

Dosage form

FOAM

Route

INTRAUTERINE

TE code

Not listed

Application

NDA 212279

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9034300Oct 15, 2030in 4 yr 5 mo
ProductU-2663
9259494May 04, 2035in 9 yr
ProductU-2663
9849199Feb 11, 2036in 9 yr 9 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.